The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).
Study Type
OBSERVATIONAL
Enrollment
120
Lumbar Spine fusion with OssiMend™ Bioactive Moldable
San Diego Neurosurgery
Encinitas, California, United States
NOT_YET_RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGUniversity Orthopaedic Associates, Division of OrthoNJ
Somerset, New Jersey, United States
NOT_YET_RECRUITINGFusion Success
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
Time frame: 12 months
Visual analog scale (VAS) of back and leg (left and right)
Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)
Time frame: 12 months
Oswestry Lower Back Pain Questionnaire
Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire
Time frame: 12 months
SF36
Pain and function as measured by the Short - Form 36
Time frame: 12 months
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McKenzie-willamette Medical Center
Eugene, Oregon, United States
COMPLETED